MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Model Number 5195501400

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Deformity/ Disfigurement (2360); Prolapse (2475); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, the legal representative stated severe pain with daily activities, dyspareunia.A portion of the mesh was excised and removed on (b)(6) 2016 due to exposure.Additional surgery to remove the remainder of the mesh was done on (b)(6) 2018 due to exposure and thinning of mesh.Stated vaginal prolapse, urinary incontinence, physical deformity and the loss of the ability to perform sexually.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10222149
• MDR Text Key: 197353071
• Report Number: 2125050-2020-00479
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195501400
• Device Catalogue Number: 519550
• Device Lot Number: 5726452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention